Accession Number : ADA336523

Title :   Preventing Fatique in Women with Breast Cancer Treated with Chemotherapy.

Descriptive Note : Annual rept. 23 Sep 96-22 Sep 97,

Corporate Author : ROCHESTER UNIV NY

Personal Author(s) : Morrow, Gary R.

PDF Url : ADA336523

Report Date : OCT 1997

Pagination or Media Count : 29

Abstract : This is the first annual report on a randomized, double-blind, placebo-controlled clinical trial with 130 consecutive breast cancer patients who are being studied over four successive chemotherapy treatments to assess if an antidepressant drug can attenuate or prevent the development of fatigue in women during chemotherapy treatment. We are also examining the potential role of depression, sleep disturbance and the cytokine TNF-alpha in the development of fatigue during chemotherapy treatment. Patients are randomized to take the antidepressant paroxetine (Paxil(R)) or placebo once a day during the trial. They complete standardized psychometric measures of fatigue and depression on the 7th day following each of the four chemotherapy cycles. Patient motion is assessed as a concomitant measure of fatigue by ambulatory electronic monitoring during the second and fourth assessments. Blood levels of TNF-alpha are also measured at these two treatments. Patient accrual began at the first site in November, 1996 and will begin at an additional later this month. We anticipate no problems in completing the study as planned.

Descriptors :   *PREVENTIVE MEDICINE, *CHEMOTHERAPY, *FATIGUE(PHYSIOLOGY), *PSYCHOANALEPTIC AGENTS, *BREAST CANCER, MONITORING, CLINICAL MEDICINE, CYCLES, CHEMICAL REACTIONS, PATIENTS, LIFE SPAN(BIOLOGY), PLACEBOS, WOMEN, PSYCHOMETRICS.

Subject Categories : Biology
      Medicine and Medical Research
      Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE